Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC

42385-913

11-digit product format

423850913

Labeler code

42385

Product ID

42385-913_123cc339-261f-48d8-85e1-838fc48d3f7f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Emtricitabine and Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Laurus Labs Limited

Application

ANDA212114

Marketing category

ANDA

Marketing start

2019-07-26

Marketing end

0000-00-00

Substance

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

200 mg/1; mg/1

Pharmacologic classes

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record